Dupilumab Found Beneficial in COPD with Type 2 Inflammation: Daily Dose

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On March 6, 2025, we reported on a pooled analysis of two phase 3 clinical trials presented at the 2025 American Academy of Allergy, Asthma, & Immunology Annual Meeting that was designed to examine the safety and efficacy of dupilumab in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation.

The study

Researchers conducted an analysis of the BOREAS and NOTUS studies, which assessed current/former smokers with moderate to severe COPD and type 2 inflammation (blood eosinophil count 300 cells/μL) primarily receiving background and stable triple therapy to see if 300 mg dupilumab every 2 weeks reduced the annual exacerbation rate over 52 weeks.

Pooling data from the BOREAS and NOTUS studies, investigators assessed 1874 adults with moderate to severe COPD and type 2 inflammation who were current or former smokers to find out the impact of dupilumab on exacerbations and lung function compared to placebo, as well as the drug’s safety profile in a larger population.

The findings

The primary endpoint of annualized moderate or severe exacerbation rate showed a 31% reduction with dupilumab versus placebo (nominal P < .0001). Lung function measurements indicated that the change from baseline in prebronchodilator FEV₁ at week 12 was greater with dupilumab (least squares mean difference, 83 mL; nominal P < .0001) and remained consistent through week 52 (73 mL; nominal P < .0001). Annualized total courses of systemic corticosteroids for exacerbations were lower with dupilumab compared with placebo (0.639 vs 0.966).

Safety outcomes were similar between treatment arms, with dupilumab showing a tolerability profile consistent with previous studies.

Authors' comments

"In two pooled phase 3 trials, dupilumab reduced moderate or severe exacerbations, improved lung function, reduced total SCS courses due to exacerbations, and had safety consistent with the known safety profile."

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